AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating

AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating is an FDA 510(k)-cleared medical device (K142983) manufactured by Angioscore, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 2015. Regulation: 8.